ASCO, Author Interviews, Cancer Research, Leukemia, UC Davis / 28.05.2020

MedicalResearch.com Interview with: Brian A. Jonas, M.D., Ph.D. UC Davis Health System MedicalResearch.com: What is the background for this study? At this year’s American Society of Clinical Oncology (ASCO) and European Hematology Association (EHA) virtual meetings, we presented data on the rapidity and likelihood of response to venetoclax treatments, and its associated characteristics, in older patients with newly diagnosed acute myeloid leukemia (AML). We evaluated data from two clinical trials of venetoclax in combination with azacitidine, or decitabine (M14-358), or low-dose cytarabine (LDAC) (M14-387) in this patient population. (more…)
Author Interviews, COVID -19 Coronavirus, JAMA / 28.05.2020

MedicalResearch.com Interview with: Soumya Sen PhD McKnight Presidential Fellow Mary & Jim Lawrence Fellow of Carlson School Director of Research, MIS Research Center Associate Professor, Information & Decision Sciences Carlson School of Management University of Minnesota, Minneapolis, MN MedicalResearch.com: What is the background for this study? Response: As the Covid-19 pandemic unfolded across the United States, one of the greatest barriers to understanding the extent of the problem was the lack of reliable and consistent data. Some of the metrics being reported, such as case count and death, are insufficient for hospital capacity planning. Case count is a conservative estimate of the actual number of infected individuals in the absence of community-wide serologic testing, while death count is a lagging metric and insufficient for proactive hospital capacity planning. A more valuable metric for assessing the effects of public health interventions on the health care infrastructure is hospitalizations. Therefore, the Medical Industry Leadership Institute (MILI) and the Management Information Systems Research Center (MISRC) at the Carlson School of Management launched the COVID-19 hospitalization tracking project in March to consistently track and report daily hospitalizations from all reporting states. Tracking daily hospitalization data is a major step forward in quantifying the current impact on local hospital systems, modeling and  forecasting future utilization needs, and tracking the rate of change in the disease severity. It is also useful for understanding the role of health policy interventions in slowing or reducing the impact of the pandemic. (more…)
Author Interviews, Cancer Research, JAMA, Yale / 28.05.2020

MedicalResearch.com Interview with: Daniel J. Boffa, MD Associate Professor of Thoracic Surgery Yale School of Medicine MedicalResearch.com: What is the background for this study? Response: The study examined networks that formed around hospitals that had been previously ranked in the top-50 by US News and World Report.  These top-ranked hospitals have shared their brand with hospitals in their network, which leads some people to believe that the care is the same at top-ranked hospitals and their affiliate hospitals.  We wanted to determine if outcomes after complex surgical procedures were truly the same at affiliate hospitals and top-ranked hospitals.  (more…)
Author Interviews, COVID -19 Coronavirus / 27.05.2020

MedicalResearch.com Interview with: Jianfeng Zhou MD, PhD Department of Hematology, Tongji Hospital Tongji Medical College Huazhong University of Science and Technolog Wuhan, Hubei, China MedicalResearch.com: What is the background for this study? Response:  There is accumulating evidence on the key pathophysiological role of cytokines during the severe stage of COVID-19. In the context of lack of vaccine and specific antiviral agents, testing of immunomodulatory agents to reduce excessive or uncontrolled inflammation before it results in irreversible multi-organ dysfunction infection has received increasing research attention. Although several important papers have proposed JAK inhibitors as potential therapeutic targets, the role of JAK inhibitors on COVID-19 patients needs to be clarified quickly, especially in severe COVID-19 patients. (more…)
Author Interviews, Nutrition, Pediatrics, Pediatrics, Weight Research / 26.05.2020

MedicalResearch.com Interview with: Megan H. Pesch, MD, MS, FAAP Assistant Professor C.S. Mott Children’s Hospital University of Michigan MedicalResearch.com: What is the background for this study? Response: Picky eating is common among children and is often both concerning to parents. Healthcare providers may reassure parents that their child will “outgrow” picky eating, however there have been few longitudinal studies examining the trajectories of picky eating in children, as well as associated trends in their growth. In our study we examined the trajectories of picky eating in US children over a 5 year period. We also examined how these picky eating trends were associated with child characteristics, weight status and mother’s feeding behaviors. (more…)
Annals Internal Medicine, Author Interviews, Colon Cancer / 26.05.2020

MedicalResearch.com Interview with: Dr. Nastazja Dagny Pilonis, MD Maria Sklodowska-Curie Memorial Cancer Center Institute of Oncology, Warsaw, Poland MedicalResearch.com: What is the background for this study? Response: Currently recommended 10-year interval between screening colonoscopies is based on the limited evidence. We decided to assess what is the risk of colorectal cancer and colorectal cancer death after singe negative screening colonoscopy. (more…)
Author Interviews, Brigham & Women's - Harvard, Cognitive Issues, Heart Disease, JACC, Lipids / 23.05.2020

MedicalResearch.com Interview with: Robert P. Giugliano, MD, SM Senior Investigator, TIMI Study Group Cardiovascular Medicine Brigham and Women's Hospital Professor of Medicine Harvard Medical School Boston, MA  MedicalResearch.com: What is the background for this study? Response: Some prior studies had suggested that lipid lowering therapies were associated with impaired cognition.  We sought to explore this question in a prospectively designed substudy of the large FOURIER randomized, double-blind clinical trial utilizing patient self-surveys administered the end of the study to determine whether patients themselves noticed any changes in cognition over the duration of the trial. The survey tool was a shortened version of the Everyday Cognition Questionnaire (see attached) that asks patients 23 questions that assess memory and executive function (including subdomains of planning, organization, and divided attention). The questions are in the format of "Compared to the beginning of the study, has there been any change in .....", and are graded as 1=better/no change, 2=questionable/occasionally worse, 3=consistently a little worse, 4=consistently much worse. (more…)
Author Interviews, COVID -19 Coronavirus, Race/Ethnic Diversity / 21.05.2020

MedicalResearch.com Interview with: Charles H. Hennekens, MD, DrPH Sir Richard Doll Professor Senior Academic Advisor FAU, Boca Raton, FL  MedicalResearch.com: What is the background for this study? Response: Blacks and other disadvantaged minorities in the United States have markedly reduced life expectancies compared with their white counterparts.  As is the case with most fatal diseases, coronavirus disease (COVID-19) is already taking a disproportionate toll on blacks and other disadvantaged minorities. (more…)
Author Interviews, OBGYNE, Pediatrics / 21.05.2020

MedicalResearch.com Interview with: Yanmin Zhu, M.S., Ph.D. Postdoctoral Research Fellow Division of Pharmacoepidemiology and Pharmacoeconomics Brigham and Women's Hospital and Harvard Medical School  MedicalResearch.com: What is the background for this study? Response: Animal studies and case reports suggest a potential teratogenic effect associated with the use of high doses of fluconazole during pregnancy. The malformations reported in case reports have a distinct phenotype, including femoral bowing, thin ribs, cleft palate, and abnormal craniofacial ossification. A few controlled studies have examined the risk of congenital malformations associated with the use of fluconazole during the first trimester, but findings are inconsistent. (more…)
AHA Journals, Author Interviews, COVID -19 Coronavirus, NYU / 21.05.2020

MedicalResearch.com Interview with: Shadi Yaghi, MD Assistant Professor Department of Neurology at NYU Grossman School of Medicine Director, Clinical Vascular Neurology Research, NYU Langone Health Director, Vascular Neurology, NYU Langone Hospital-Brooklyn  MedicalResearch.com: What is the background for this study? Response: Our aim was to determine the characteristics of imaging proven ischemic stroke in the setting of COVID-19 infection and compare them to those of ischemic stroke but without COVID-19 infection. (more…)
Author Interviews, Cancer Research, Melanoma, Nature / 21.05.2020

MedicalResearch.com Interview with: Dr. Kelly Brooks PhD Research Officer QIMR Berghofer Medical Research Institute     MedicalResearch.com: What is the background for this study? Response: There are approximately 175 new cases a year for melanomas inside the eye called uveal melanomas. These cancers spread to other sites of the body in about half of patients. Uveal melanomas are very different to skin melanomas and so far no effective treatment have been approved to treat uveal melanoma once it has spread. We sequenced uveal melanoma tumours from over 100 different patients to look at what mutations are responsible for tumour growth and development.  (more…)
Author Interviews, Dermatology / 21.05.2020

MedicalResearch.com Interview with: Dr. Melanie D. Palm, MD, MBA Board-certified dermatologist and cosmetic surgeon San Diego, CA Clinical investigator in the Restylane Kysse phase 3 Galaderma trial Dr. Palm discusses the recent announcement that the FDA has approved Restylane® Kysse for lip augmentation and the correction of upper perioral rhytids (wrinkles)  in adults over the age of 21.   MedicalResearch.com: What is the background for this announcement?
    • Restylane® Kysse has been approved and used in Europe and Canada for several years. It is now the first FDA-approved hyaluronic acid (HA) lip filler in the U.S. formulated with XpresHAn Technology™ (pronounced ex-'spre-shan’) for smooth, natural-looking results.
    • It is FDA-approved for use not only in the lip but for improvement of upper lip lines.
    • Restylane Kysse is the third product (following Restylane Defyne and Restylane Refyne) in the Restylane family of fillers to use XpresHAn Technology™ which allows for a gel that integrates into the skin for natural expression in motion
(more…)
Author Interviews, Gender Differences, JAMA, Surgical Research, University of Pittsburgh / 21.05.2020

MedicalResearch.com Interview with: Sara P. Myers, M.D., Ph.D. University of Pittsburgh School of Medicine  MedicalResearch.com: What is the background for this study? Response: Compared to other fields, medicine, and especially academic surgery and its subspecialties, trail with respect to gender diversity. Considering that these fields were traditionally male-dominated, two issues that may present ongoing challenges to the retention and promotion of women are pro-male bias and negative stereotypes about women. Training specific to pursuing a surgical career begins in residency, so it is important to understand how these issues affect motivation and achievement during this formative period. In our study we first evaluated the association between pro-male bias and research-related career engagement using a survey methodology, and then looked at whether evoking negative stereotypes about women was associated with reduced performance on a simulated technical skill assessment called the Fundamentals of Laparoscopic Surgery (FLS) assessment.  (more…)
Author Interviews, Cancer Research, COVID -19 Coronavirus / 19.05.2020

MedicalResearch.com Interview with: Paolo A. Ascierto, MD Melanoma. Cancer Immunotherapy and Development Therapeutics Unit Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale" Napoli - Italy  MedicalResearch.com: What is the background for this study? What are the main findings? Response: As we know, in Covid-19 pneumonia, especially in its complication “acute respiratory distress syndrome (ARDS)”, a key role is played by the immune system. We know that when we treat a tumor with immunotherapy, it could give side effects because the stimulated immune system produces a series of substances to destroy the tumor. Sometimes, the immune system can also give side effects related to a hypersecretion of some cytokines, such as IL 6, the target of tocilizumab. This condition is called cytokine storm, or better, cytokine release syndrome (CRS).Oncologists use tocilizumab in the management of CRS that can occur following the use of bispecific antibodies, or recently, the use of CAR-T cell therapy, where such drug is approved for CRS treatment.  (more…)
Author Interviews, Cancer Research, Lancet, Nature / 19.05.2020

MedicalResearch.com Interview with: Matthew Galsky, MD Icahn School of Medicine at Mount Sinai New York, NY MedicalResearch.com: What is the background for this study? Response: Standard first-line treatment for metastatic urothelial (bladder) cancer has been platinum-based chemotherapy for decades. In 2016, atezolizumab, an immunotherapy that inhibits PD-L1, received accelerated approval by the FDA for the treatment of metastatic urothelial cancer for patients progressing despite prior platinum-based chemotherapy and this was followed by approvals for 4 additional PD-1 or PD-L1 inhibitors in this setting over the next couple years. With this first new drug class approved, representing the first new drugs approved for metastatic urothelial cancer for decades, logical question arose (a) should we combine these drugs with platinum-based chemotherapy in the first-line metastatic treatment setting and (b) is there a role to replace first-line chemotherapy with atezolizumab monotherapy. The IMvigor 130 trial was designed to address these questions. The trial enrolled 1213 patients who were randomized to treatment with (a) atezolizumab plus platinum-based chemotherapy, (b) placebo + platinum-based chemotherapy, or (c) atezolizumab monotherapy. The trial employed a hierarchical analysis plan such that comparisons between arms for certain endpoints could only be formally tested if other the preceding comparisons demonstrated a significant improvement.  (more…)
ASCO, Author Interviews, Cancer Research / 19.05.2020

MedicalResearch.com Interview with: Dr. Jesus G. Berdeja, MD Director of Myeloma Research Sarah Cannon Nashville, TN MedicalResearch.com: What is the background for this study? Response: Despite many advances in the treatment of multiple myeloma in recent years, the majority of patients will progress through all available therapies and ultimately succumb to their disease.  Thus there is still a high unmet medical need. The Phase 1b/2 CARTITUDE-1 study evaluates the safety and efficacy of JNJ-4528, an investigational BCMA-directed CAR-T therapy, in the treatment of patients with relapsed or refractory multiple myeloma. Participants in this study have already tried approved therapies, and had received a median of five prior treatment regimens and their median overall survival is less than 12 months.  (more…)
Author Interviews, JAMA, Orthopedics, Race/Ethnic Diversity, Surgical Research / 19.05.2020

MedicalResearch.com Interview with: Alyson Cavanaugh, PT, PhD Joint Doctoral Program in Epidemiology University of California, San Diego/ San Diego State University MedicalResearch.com: What is the background for this study? Response: More than 700,000 total knee replacements are performed annually in the United States, but there is a racial disparity in outcomes after the surgery. If the knee replacement procedure is considered a highly effective treatment, why don't black women present with the same outcomes as whites? Physical function when going into surgery has a large impact on the potential functional outcomes after surgery. Our hypothesis was that black women were presenting to surgery with poorer physical function, which was contributing to poorer functional outcomes after surgery. (more…)
Author Interviews, JAMA, STD / 19.05.2020

MedicalResearch.com Interview with: Barbara Van Der Pol, PhD, MPH President, American STD Association President-Elect, International Society fo STD Research Professor of Medicine & Public Health Director, STD Diagnostics Lab Director, UAB STD Clinical Research Organization University of Alabama at Birmingham Birmingham, AL  35294 MedicalResearch.com: What is the background for this study? Response: For many decades, public health programs focused on control and prevention of sexually transmitted infections (STI) have relied on lab based tests that required a 1-day to 1-week wait for test results.  Efforts to shorten the duration of infection lead to treating at the time of the clinic visit based on the association between certain clinical signs or symptoms and the likelihood of infection. Unfortunately, more than ½ of infected persons do not have signs or symptoms so they receive no treatment until test results are available. Thus, a test that could be performed at the clinical site with a limited wait time would improve the accuracy of treatment and shorten the duration of infection. Such a strategy will hopefully reduce the number of return clinic visits, the possibility of transmission, and the potential for consequences of untreated infection such as infertility.  (more…)
Author Interviews, Cost of Health Care, JAMA / 19.05.2020

MedicalResearch.com Interview with: James D. Chambers, PhD, MPharm, MSc Associate Professor of Medicine Tufts Medical Center Institute for Clinical Research and Health Policy Studies MedicalResearch.com: What is the background for this study? Response: We know that biosimilars have not had the same uptake in the US as they have had elsewhere. We know that this is in part due to reference product manufacturer tactics to delay biosimilar market entry and patent disputes. In this study we examined whether lack of preferred coverage by commercial health insurers may also play a role. (more…)
Author Interviews, JAMA, Pediatrics, Social Issues, Technology / 18.05.2020

MedicalResearch.com Interview with: Pooja S. Tandon, MD, MPH Center for Child Health, Behavior and Development Seattle Children's Research Institute MedicalResearch.com: What is the background for this study? Response: Cell phone use is common among middle and high school students, yet we do not have an understanding of school cell phone policies and practices in the U.S. We conducted a survey of public schools serving grades 6-12. The survey sent to over 1,100 school principals, representing a national sample of schools across the U.S., asked questions about the presence of a cell phone policy for students and staff and restrictions on phone use. Additional questions addressed consequences of policy violation, the use of cell phones for curricular activities and principals’ attitudes toward cell phone policies. (more…)
Author Interviews, Cannabis, CDC, JAMA, Pediatrics, Tobacco Research / 18.05.2020

MedicalResearch.com Interview with: Susan Hocevar Adkins, MD Lead Author, Senior Medical Officer, and Commander United States Public Health Service CDC MedicalResearch.com: What is the background for this study? Response: Since August 2019, the Centers for Disease Control and Prevention (CDC), the US Food and Drug Administration (FDA), and state, local, and territorial health departments have been investigating a national outbreak of e-cigarette, or vaping, product use-associated lung injury (EVALI). Although clinical presentation and outcomes of EVALI patients generally have been reported, data on adolescent patients are more limited. This article fills this gap by using data from national EVALI surveillance at CDC to examine demographic, substance use, and clinical characteristics of adolescent EVALI patients relative to young adult and adult EVALI patients. (more…)
Author Interviews, JAMA, Surgical Research, Weight Research / 16.05.2020

MedicalResearch.com Interview with: Wei Bao, MD, PhD Assistant Professor Department of Epidemiology, College of Public Health, University of Iowa, Iowa City, IA 52242 and Dr. Yangbo Sun, PhD (Former postdoc research scholar at University of Iowa) Tenure-track Assistant Professor The University of Tennessee Health Science Center.   MedicalResearch.com: What is the background for this study? Response: Obesity is a rising epidemic in the United States and worldwide. Bariatric surgery has been shown to be the most effective and durable treatment for clinically morbid obesity which is difficult to reverse through traditional approaches such as lifestyle intervention. There has been long-standing uncertainty and debate regarding the value of pre-operative weight loss as a requirement for bariatric surgery. Meanwhile, one of the major indicators for surgery outcomes is 30-day mortality after surgery, which is especially important for bariatric surgery because the vast majority of the patients undergoing bariatric surgery are voluntary and if the surgery were not performed, they are not supposed to die in short term. So far, the association of pre-operative weight loss with 30-day mortality after bariatric surgery remains unclear. Therefore, in this study, we examined the associations of pre-operative BMI and weight loss with 30-day mortality following bariatric surgery using a large database among ~500,000 patients who underwent bariatric surgery in the United States and Canada. (more…)
Author Interviews, Diabetes, Genetic Research, Pancreatic / 15.05.2020

MedicalResearch.com Interview with: Dr. Núria Malats, MD PhD, Head of the Genetic and Molecular Epidemiology Group Spanish National Cancer Research Centre (CNIO)  MedicalResearch.com: What is the background for this study? Response: The high mortality of pancreatic cancer is a consequence of late diagnosis because of the absence of symptoms in the earliest stages, and defining risk populations is therefore crucial to be able to carry out diagnostic tests that reveal the presence of the tumour as early as possible. Diabetes and pancreatic cancer are connected because the pancreas secretes insulin; in diabetic people, this does not occur in a normal way. It is estimated that around 50% of patients with pancreatic cancer presents diabetes. But it is an outstanding challenge for researchers to figure out which is the cause and which is the consequence.  To conduct the study, the team used data from more than 3,500 persons from PanGenEU, a large European study involving centres from six countries, including Spain, and led by Malats, to analyse the relationship between multiple risk factors and pancreatic cancer. (more…)
Author Interviews, Brigham & Women's - Harvard, Cost of Health Care, Heart Disease, Race/Ethnic Diversity, Statins / 14.05.2020

MedicalResearch.com Interview with: Dr. Ankur Pandya, PhD Assistant Professor of Health Decision Science Department of Health Policy and Management Harvard T.H. Chan School of Public Health MedicalResearch.com: What is the background for this study? Response: The 2013 ACC-AHA cholesterol treatment guidelines greatly expanded statin medication eligibility for individuals between the ages of 40-75 years without known cardiovascular disease, and there was some concern that African Americans at "intermediate risk" per those guidelines could be (arguably) overtreated with statins. The 2018 ACC-AHA guidelines included coronary artery calcium assessment for individuals at intermediate cardiovascular disease risk; those with a "zero" calcium score and no other risk factors would now change the eligibility (from indicated statin to not indicated). (more…)
Author Interviews, Infections, OBGYNE, Sexual Health, STD / 13.05.2020

MedicalResearch.com Interview with: Gregory Kaufman, M.D. Senior Vice President Global Clinical and Medical Affairs Specialty at Lupin MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by trichomoniasis?  How common is this infection? Response: The Phase 3 trial evaluated the effectiveness and safety of a single oral dose of Solosec® (secnidazole) 2g oral granules for the treatment of trichomoniasis in adult women. Top-line results were positive and showed that Solosec was generally well-tolerated. Trichomoniasis is the most common non-viral sexually transmitted infection (STI) in the U.S., and is caused by a protozoan parasite called Trichomonas vaginalis.[i] Trichomoniasis affects 3 to 5 million people in the U.S.,[ii] and is four- to five-times more prevalent in in women, compared to men.[iii]. (more…)
Author Interviews / 13.05.2020

MedicalResearch.com Interview with: Celine Latulipe PhD Associate Professor University of Manitoba MedicalResearch.com: What is the background for this study? What are the main findings? Response: We wanted to find out how many hospitals offer proxy accounts for caregivers of adult patients. Most patient portal systems allow proxy accounts for parents of pediatric patients, so we know the underlying systems support the creation of proxy accounts. When we were starting this research, the two big healthcare systems where I was located did NOT offer such proxy accounts for caregivers of adult patients, and a staff person at one of those hospitals suggested adult patients share their passwords with their caregiver, if the caregiver needed access to the portal. As a computer scientist, I am well aware of the security and privacy risks associated with password sharing, and I was appalled by this advice. So we did this survey across the US and we found that 45% of the staff contacted in our study gave similar password sharing advice. This is hugely problematic. Caregivers using a patient's password means the caregiver can see everything in the medical record, including things the patient might not want the caregiver to know, such as past diagnoses of stigmatized illnesses, substance abuse or reproductive health decisions. Also, because password re-use is common across systems, a caregiver with a patient's portal password may now have access to the patient's online banking. (more…)
Author Interviews, Dermatology / 13.05.2020

MedicalResearch.com Interview with: Brian S. Kim, MD, MTR, FAAD Associate Professor of Medicine (Dermatology) Co-Director, Center for the Study of Itch and Sensory Disorders Division of Dermatology, Department of Medicine Washington University School of Medicine St. Louis, MO  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Itch is the central and most debilitating symptom of atopic dermatitis. However, surprisingly, measuring itch or quality of life in clinical trials is not often a primary endpoint. Therefore, this study focuses in very detailed fashion on how ruxolitinib cream improves pruritus in a clinically meaningful way and its ultimate impact on quality of life. What patients want to know at the end of the day is how much will this drug change my life?  Not, whether it statistically beat out a placebo group. Indeed, what this study shows is that ruxolitinib cream has a major impact on itch in a meaningful way that is also tied to improvements in quality of life. (more…)
AACR, Author Interviews, Boehringer Ingelheim, Cancer Research / 13.05.2020

MedicalResearch.com Interview with: Dr. Udai Banerji, MD The Institute of Cancer Research and The Royal Marsden MedicalResearch.com: What is the background for this study? Response: Not only have I been working in the RAS mutations oncology world for a while, but I also have prior preclinical experience working with VS-6766 (RAF/MEK inhibitor) and defactinib (FAK inhibitor), the two drugs in the Phase 1 study that was presented at the American Association for Cancer Research (AACR) annual medical meeting on April 27th. It is important to know that there is a great significant medical need for novel treatments for KRAS mutant tumors, which are difficult to treat, aggressive, and quite common across advanced solid tumors, including low-grade serous ovarian cancer (LGSOC), non-small cell lung cancer (NSCLC) and colorectal cancer (CRC), resulting in the need for novel treatments in an area of significant medical need. I felt that early signals in preclinical research warranted a clinical trial; so that, combined with my RAS experience, made pursuing the Phase 1 study a clear fit. A clinical trial setting allowed us to explore RAF and RAS inhibitor combinations in multiple tumor trials, which was our aim. The data presented at AACR convey safety and dose response results from the dose-escalation portion and expansion cohorts from an open-label, investigator-initiated Phase 1 study evaluating the combination of VS-6766 (RAF/MEK inhibitor) and defactinib (FAK inhibitor) therapy in patients with LGSOC and KRAS mutant NSCLC. The introductory data described in the study suggest that a novel intermittent dosing schedule of RAF/MEK and FAK inhibitor combination therapy has promising clinical activity in patients with KRAS mutant LGSOC and KRASG12V mutant NSCLC, including patients formerly treated with a MEK inhibitor. Expansion cohorts remain ongoing.  (more…)